UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036005 |
|---|---|
| Receipt number | R000041010 |
| Scientific Title | Effect of muscular function therapy on tongue thrust- Investigation by multi modality analysis |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2019/02/25 16:13:34 |
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Basic information
Public title
Effect of muscular function therapy on tongue thrust- Investigation by multi modality analysis
Acronym
Effect of muscular function therapy on tongue thrust
Scientific Title
Effect of muscular function therapy on tongue thrust- Investigation by multi modality analysis
Scientific Title:Acronym
Effect of muscular function therapy on tongue thrust
Region
| Japan |
Condition
Condition
tongue thrust
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to measure the temporal movement of the tongue and oropharyngeal part during swallowing by using MRI movie that has never been adapted during swallowing in the group with tongue protruding habits, It is to investigate the mutual relationship in the temporal change of the tongue pressure distribution, the change of the masticatory muscle, the activity of the muscularis muscle around the oral cavity, the change of the peripheral blood flow rate of the masticatory muscle, and to elucidate the influence on the jaw and dentition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI movie
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
myofunctional therapy
Interventions/Control_2
tongue thrust
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy person
Key exclusion criteria
birth defect syndrome
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MIYAMOTO JUN |
Organization
Tokyo medical and dental university
Division name
Department of Maxillofacial Orthognathics
Zip code
Address
1-5-45 Yushima, Bunkyu-ku, Tokyo
TEL
0338136111
j-miyamoto.mort@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NAKAMURA RURIKO |
Organization
Tokyo medical and dental university
Division name
Department of Maxillofacial Orthognathics
Zip code
Address
1-5-45 Yushima, Bunkyu-ku, Tokyo
TEL
0358035536
Homepage URL
ruriiiiiko@gmail.com
Sponsor or person
Institute
Tokyo medical and dental university
Department of Maxillofacial Orthognathics
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 25 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041010
